Facility

Avent S. de R.L. de C.V.

19 recall(s) on record — most severe on record: Class I.

Key facts

19recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007596547
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	Ave Noruega Edificio D-1B TIJUANA Baja California, MX 22116
Registration status	Active · expires 2026
Parent company	Avanos Medical, Inc. (owner-operator 2022573)
Brand names	ON-Q CATHETER, ON-Q ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER; ON-Q* Antimicrobial Expansion Kits with SILVERSOAKER* Catheter; ON-Q; ON-Q ANTIMICROBIAL EXPANSION-Q KITS WITH SILVERSOAKER* ANTIMICROBIAL CATHETER AND NRFit" CONNECTOR

Activity by year

Recalls (19)

Devices registered here (1)

Catheter, Conduction, Anesthetic
Product code BSO (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5120

Recalls & enforcement

20261 record

Class IIOngoing2026-04-30
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

20251 record

Class IOngoing2025-03-19
Lack of sterility assurance for closed suction catheter systems

20243 records

Class IIOngoing2024-05-31
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Class IIIOngoing2024-03-04
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
Class IOngoing2024-01-16
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

20235 records

Class IIOngoing2023-10-13
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
Class IICompleted2023-08-01
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Class IITerminated2023-04-24
Some of the ambIT kits were potentially distributed without an air in-line filter.
Class ITerminated2023-02-03
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Class IITerminated2023-02-03
Incorrect expiration date.

20222 records

Class IITerminated2022-09-14
Sterile extension sets were distributed without an expiration date
Class ITerminated2022-03-21
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

20212 records

Class IITerminated2021-12-22
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Class IITerminated2021-11-22
Product was distributed with incorrect expiration date.

20203 records

Class IITerminated2020-10-16
Detachment of the Male AIV Adaptor from the Y-Connector.
Class IITerminated2020-07-29
Devices had cracked or detached from the feeding tube body
Class IITerminated2020-03-16
The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted.

20192 records

Class IITerminated2019-11-05
Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially blocked. This may cause the closed suction catheters (CSCs) to inadequately suction secretions and/or saline fluids form t…
Class IITerminated2019-10-08
The connector piece to the PEG tube does not pass over the guidewire.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Avent S. de R.L. de C.V. (FEI 3007596547) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007596547-avent-s-de-r-l-de-c-v/

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